Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil (epidarc)

University Hospital, Rouen

Status and phase: Completed; Phase 4

Conditions: Fetal Cardiac Rhythm Abnormalities

Treatments: Drug: ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01686347

2010/146/HP

Details and patient eligibility

About

The aim of the investigators study is to demonstrate the association between fetal cardiac rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine and/or sufentanil.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years old or more

• nulliparous

  _ one fetus

• head first

• spontaneous labor

• epidural analgesia

• no fetal cardiac rhythm abnormalies before the epidural analgesia

• no active management of labor during 30 minutes after the epidural analgesia induction

• at term

• signature of the consent form

Exclusion criteria

• pathological pregnancy
• low maternal blood pressure during the 30 minutes after the epidural analgesia
• uterin contraction which last for 5 minutes or more
• more than 6 uterin contractions during a 10 minutes period
• Ropivacaine contraindication
• sufentanil contraindication

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

fetal cardiac rhythm abnormally

Other group

Description:

patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction

Treatment:

Drug: ropivacaine

control group

Other group

Description:

patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction

Treatment:

Drug: ropivacaine